FDAClass IIJanuary 11, 2017

Gomco Circumcision Clamps with separate O-Ring recall

Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be…

Why was Gomco Circumcision Clamps with separate O-Ring recalled?

Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Material Code MG096R  (1.1 CM) MG097R  (1.3 CM) MG227 (1.45CM) MG228  (1.6CM) MG229  (2.1 CM) MG230  (2.6CM)

Product
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be…
Recalling firm
Aesculap Implant Systems LLC
Quantity
437 units
Distribution
Nationwide Distribution
Recall date
January 11, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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